Due to the size of this blog post, we have moved the information to a dedicated page on our website. You may access the page by clicking the following link:
- Scientific Principles
- _Growth-based Methods
- _Viability Staining and Laser Excitation
- _Detection of Cellular Components
- _Optical Spectroscopy
- _Nucleic Acid Amplification
- _MEMs
- Product Matrix
- How to Validate
- Regulatory
- _Annex 1 Revision
- _Rapid Sterility Testing of ATMPs
- _Changing Acceptance Levels
- _US Food and Drug Administration (FDA)
- _European Medicines Agency (EMA)
- _Australia TGA
- _Japan PMDA
great
ReplyDeleteexcellent. Can you explain why so many companies have gone in for RT PCR and why RT LAMP which would have given results at point of care leading to isolation and interruption of transmission have not found favour with both the companies or regulatory authorities ?
ReplyDeleteGreat question. This may have more to do with patent protection for the newer LAMP methods as compared with conventional RT-PCR methods.
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